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| ID | Type | Description | Link |
|---|---|---|---|
| 80-83910-98-1158 | Other Grant/Funding Number | ZonMw |
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The goal of this clinical trial is to learn if training primary care providers on treatment of insomnia can improve insomnia symptoms in patients. Researchers will compare insomnia symptoms of patients receiving care from trained practices with patients receiving care from control practices (providing care-as-usual), to see if the training helps to provide improved insomnia care. Participants will be asked to complete four questionnaires and some participants will be invited for an insomnia consultation in primary care by their primary care providers (PCP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training with pro-active identification | Experimental | For detailed description of the intervention, see the separate section on interventions. |
|
| Training without pro-active identification | Experimental | For detailed description of the intervention, see the separate section on interventions. |
|
| Control | No Intervention | Care as usual according to national applicable primary guide guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training | Other | A 4-hour training for PCPs consisting of an onsite training, an e-learning and a webinar on the treatment of insomnia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient reported insomnia symptoms using the Insomnia Severity Index (ISI) | Change is measured linearly using the Insomnia Severity Index. Scores range from 0 to 28 points in which higher scores represent a worse outcome. Secondly, the categorically defined treatment response is established 2 months after baseline questionnaire (remission = ISI score < 11, ISI score reduction ≥ 8). | From baseline to measurements at 2, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported non-pharmacological 'sleep consultation' | Patient report of a sleep consultation (survey answer yes/no) combined with patient reported sleep medication use (survey answer yes/no). | 12 months after baseline questionnaire |
| Report by the PCP of a non-pharmacological 'sleep consultation' |
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Inclusion criteria for a patient to be eligible to participate in this study:
Exclusion criteria:
Patients meeting any of the following criteria in the survey will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis O. Mook-Kanamori | Leiden University Medical Center (LUMC) | Principal Investigator |
| Rutger A. Middenburg | Leiden University Medical Center (LUMC) | Principal Investigator |
| Mattijs E. Numans | Leiden University Medical Center (LUMC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center (LUMC) | Leiden | South Holland | 2333ZA | Netherlands |
Due to the nature of the study blinding is not possible. Therefore, the data contains privacy sensitive information and only restricted access may be granted for unidentifiable parts of the data. It has yet to be decided which data can be acquired through restricted access.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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The cluster randomization trial involves two randomization procedures. Firstly, on primary care practice level, practices will be randomized to intervention practice or control practice. Secondly, patients in the intervention practices will be randomized to pro-active identification or no identification. Pro-actively identified insomnia patients will be reported back to the PCP.
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| Pro-active identification | Other | Pro-active identification of patients with clinical insomnia symptoms. Patients receiving care from the participating practices will be asked to fill-out the Insomnia Severity Index (ISI).The ISI is used to identify patients with clinical insomnia symptoms in the general practice. Trained practices will receive feedback on the ISI for half of the patients with clinical symptoms according to the ISI. |
|
PCP reported sleep consultation (survey answer yes/no) combined with PCP reported sleep medication use (survey answer yes/no). |
| 12 months after baseline questionnaire |
| Change in patient reported depression symptoms | Measured linearly using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27 points in which higher scores represent a worse outcome. | From baseline to measurements at 2, 6 and 12 months |
| Change in patient reported anxiety symptoms | Measured linearly using the General Anxiety Disorder Questionniare (GAD-7). Scores range from 0 to 21 points in which higher scores represent a worse outcome. | From baseline to measurements at 2, 6 and 12 months |
| Change in patient reported general health status | Measured with the Short Form-36 questionnaire (SF-36). Scores represent the percentage of total possible score achieved, ranging from 0 to 100. A higher score represents a better outcome. | From baseline to measurements at 2, 6 and 12 months |
| Change in report of sleep medication use | Patient reported use of sleep medication in the past two weeks (survey answer yes/no). | From baseline to measurements at 2, 6 and 12 months |
| D001523 |
| Mental Disorders |